Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432445
Status:
TERMINATED
Last Update Posted:
2015-02-27
First Post:
2007-02-05
Brief Title:
Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Trial of Proton Beam Radiation Therapy for Intra- and Periocular Retinoblastoma
Status:
TERMINATED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention
Detailed Description:
External photon beam radiation therapy which is current standard of care has been used in the treatment of retinoblastoma It is a form of radiation therapy in which the radiation is delivered by a machine pointed at the area to be radiated
Proton beam radiation therapy is a form of external photon beam radiation therapy but it may be more effective because its adjusted dosing delivers less radiation to surrounding areas of the tumor which helps preserve other tissues and cause fewer side effects
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study Your eye doctor will perform an assessment of your eye including an exam while you are under anesthesia This exam will include a dilated eye exam photography of your affected eye by a Ret-Cam ultrasound of your affected eye and imaging scans such as computed tomography CT or magnetic resonance imaging MRI if the doctor thinks it is necessary The assessments will be done to check and confirm the status of the disease
After diagnosis of retinoblastoma the study doctor will first see if external photon beam radiation therapy is a reasonable treatment option for you If external photon beam radiotherapy is deemed appropriate for you you will be eligible to receive proton beam radiation therapy in this study
If you are found to be eligible to take part in this study you will be treated with proton beam radiation therapy Treatment will begin within 1 week of referral to the M D Anderson Proton Center It will be given daily for 5 days in a row each week except for Saturdays Sundays and holidays The whole treatment will take about 4-6 weeks
Within 2-4 weeks after completion of therapy you will have an eye exam performed under anesthesia like the one during screening You will have repeated eye exams under anesthesia depending on the appearance and response of the tumor to therapy This will occur about every 1-4 months
You will continue to have these eye exams until the tumors are considered to be stable or unless your disease gets worse
If the disease gets worse or you experience any intolerable side effects you may be taken off treatment
You will be required to have lifelong eye and medical assessments to continue to monitor you for disease If no disease is found 5 years after completion of proton beam radiation therapy you will be considered free of disease You will then have annual yearly eye and pediatric assessment through adulthood
This is an investigational study Up to 20 patients will take part in this study All will be enrolled at MD Anderson
Proton beam radiation therapy is a form of external photon beam radiation therapy but it may be more effective because its adjusted dosing delivers less radiation to surrounding areas of the tumor which helps preserve other tissues and cause fewer side effects
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study Your eye doctor will perform an assessment of your eye including an exam while you are under anesthesia This exam will include a dilated eye exam photography of your affected eye by a Ret-Cam ultrasound of your affected eye and imaging scans such as computed tomography CT or magnetic resonance imaging MRI if the doctor thinks it is necessary The assessments will be done to check and confirm the status of the disease
After diagnosis of retinoblastoma the study doctor will first see if external photon beam radiation therapy is a reasonable treatment option for you If external photon beam radiotherapy is deemed appropriate for you you will be eligible to receive proton beam radiation therapy in this study
If you are found to be eligible to take part in this study you will be treated with proton beam radiation therapy Treatment will begin within 1 week of referral to the M D Anderson Proton Center It will be given daily for 5 days in a row each week except for Saturdays Sundays and holidays The whole treatment will take about 4-6 weeks
Within 2-4 weeks after completion of therapy you will have an eye exam performed under anesthesia like the one during screening You will have repeated eye exams under anesthesia depending on the appearance and response of the tumor to therapy This will occur about every 1-4 months
You will continue to have these eye exams until the tumors are considered to be stable or unless your disease gets worse
If the disease gets worse or you experience any intolerable side effects you may be taken off treatment
You will be required to have lifelong eye and medical assessments to continue to monitor you for disease If no disease is found 5 years after completion of proton beam radiation therapy you will be considered free of disease You will then have annual yearly eye and pediatric assessment through adulthood
This is an investigational study Up to 20 patients will take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01427 | REGISTRY | NCI CTRP | None |